BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT

    MDR report key: 9731293 · Received February 20, 2020

    Report

    Report Number
    9616760-2020-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    October 23, 2019
    Report Date
    February 20, 2020
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    UDI-DI
    17540262110029
    PMA / PMN Number
    K113515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGE HEALTHCARE'S INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE ISSUE IS DESIGN DEFICIENCY. THE ECG WAVEFORMS CAN BE DISPLAYED BY SIMULTANEOUS OR SEQUENTIAL ECG FORMAT OPTIONS, DEPENDING ON USER CONFIGURATION. BY DEFAULT, THE SIMULTANEOUS ECG FORMAT IS PRESENTED ON A SCALE OF 25 MM/SEC WHEREAS THE SEQUENTIAL VIEW SCALE IS DYNAMICALLY CHANGED DEPENDING ON THE MONITOR'S RESOLUTION, AND THEREFORE MAY BE DISPLAYED USING OTHER SCALES RATHER THAN 25MM/SEC. USERS WHO ARE ESTIMATING HEART RATE SOLELY BY COUNTING GRID SQUARES, MAY ASSUME THAT THE SEQUENTIAL ECG FORMAT IS PRESENTED ON A SCALE OF 25 MM/SEC, AND THEREBY MAY INACCURATELY ESTIMATE THE HEART RATE VALUE. CHANGE HEALTHCARE WILL PROVIDE A SOFTWARE UPDATE TO CORRECT THE ISSUE IN ALL AFFECTED VERSIONS OF THE SOFTWARE. IN ADDITION, CHANGE HEALTHCARE WILL PROVIDE INSTRUCTIONS (VIA FIELD SAFETY NOTICE) TO ALL AFFECTED CUSTOMERS TO INFORM THEM OF THIS ISSUE AND MITIGATIONS.

    Description of Event or Problem · 1

    THE ECG WAVEFORMS GRID SCALE, IN THE SPECIFIC "SEQUENTIAL' CONFIGURATION IS DYNAMICALLY CHANGED BASED ON THE SCREEN RESOLUTION IN USE. THEREFORE, THE ECG WAVEFORMS MAY BE DISPLAYED USING OTHER SCALES RATHER THAN 25MM/SEC. THE ON-SCREEN SCALE BAR CORRECTLY INDICATES THE ACTUAL SCALE USED FOR THE DISPLAY, AND THE HEART RATE VALUE AS SENT FROM THE CART/ CALCULATED BY THE SYSTEM IS CLEARLY DISPLAYED ON THE SCREEN AND IS NOT AFFECTED BY THE ISSUE. IN ADDITION, THE SEQUENTIAL LAYOUT USED IN THE ECG PDF REPORT IS DISPLAYED IN THE 25 MM/SEC SCALE. THE ISSUE WAS REPORTED DURING AN ECG MANAGEMENT IMPLEMENTATION BY THE CUSTOMER, PRIOR TO USING THE DEVICE IN CLINICAL USE. NO PATIENT HARM WAS REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197749 CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT CHANGE HEALTHCARE CARDIOLOGY ECG MANAGMENT DQK MCKESSON ISRAEL LTD. 14.1.1 17540262110029

    Patients

    Seq Age Sex Outcome Treatment
    1